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Pharmacovigilance

Pharmacovigilance is an activity which aims to identify, assess, understand and prevent unwanted consequences of medical drug use (Decision of the EEC Council dated November 3, 2016 No. 87 “On approval of the rules of good pharmacovigilance practice of the EAEU”, as amended by Decision of the EEC Council dated May 19, 2022 No. 81)

In compliance with international and local regulatory legal acts of EAEU member countries, pharmacovigilance is compulsory for developed and registered medical drugs, so iPharma carries out a full range of pharmacovigilance activities for medicinal products included in its pharmacovigilance system, and provides other organizations with vendor services for full or partial outsourcing of pharmacovigilance:

1

Organization of a turnkey pharmacovigilance system or performance of individual delegated functions on pharmacovigilance for developers and holders of registration certificates of medicines: development and maintenance of the Master File of the Pharmacovigilance System (MFSF) and Brief Characteristics of the Pharmacovigilance System; provision of services of an Authorized Person for Pharmacovigilance (APP), a computerized system and database for pharmacovigilance; reporting and communications with authorized bodies; ensuring compliance of the quality system of the pharmacovigilance system with the requirements of Good Pharmacovigilance Practices of the EAEU: control of documents and records, preparation and analysis of Pharmacovigilance Agreements, development of standard operating procedures (SOPs), personnel training, preparation for audits and inspections of pharmacovigilance systems, etc.

2

Pre-registration pharmacovigilance: preparing pharmacovigilance-related information in the form of a request for clinical study permit (RCS) and as a part of the registration dossier (1.10.1, 1.10.2 etc); collection, analysis and communication of reports of serious adverse events (SAE), adverse events after immunization (AEAI) and post-vaccination complications (PVC); preparing case reports of serious adverse reactions (SARs) and serious unexpected adverse reactions (SUARs) of the medicinal product under development; preparation of periodic updated reports on the safety of the drug under development (SDUR); organizing the work of the Safety Data Monitoring Committee (SDMC) with the involvement of independent experts and organizing committee meetings.

3

Post-registration pharmacovigilance: organization and conduct of post-registration safety studies (PRSS); collection, analysis, timely and correct information reports on adverse reaction (AR) cases, individual intolerance, inefficiency as well as other factors and events which affect the assessment of the risk-benefit ratio and constitute significant danger for human lives and well-being; monitoring of scientific medical literature, other sources and administrative decisions of regulatory authorities, data base analysis, collection and management of safety signals, collection and communication of AR cases, periodic safety reports (PSR) and risk management plans (RMP); updates of drug safety information in the medical use instruction (MUI, package insert - information for the patient) and General characteristics of the medicinal product (GMP).

Pharmacovigilance-related contacts:

+7 (495) 276-11-43